EP1280602B1 - Regulation d'ecoulement capillaire dans un dispositif de diagnostique fluidique - Google Patents

Regulation d'ecoulement capillaire dans un dispositif de diagnostique fluidique Download PDF

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Publication number
EP1280602B1
EP1280602B1 EP01937160A EP01937160A EP1280602B1 EP 1280602 B1 EP1280602 B1 EP 1280602B1 EP 01937160 A EP01937160 A EP 01937160A EP 01937160 A EP01937160 A EP 01937160A EP 1280602 B1 EP1280602 B1 EP 1280602B1
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sample
measurement area
channel
layer
region
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EP01937160A
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German (de)
English (en)
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EP1280602A2 (fr
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Robert Justice Shartle
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LifeScan Inc
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LifeScan Inc
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/536—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase
    • G01N33/537—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody
    • G01N33/538—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody by sorbent column, particles or resin strip, i.e. sorbent materials
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/4905—Determining clotting time of blood
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/25—Chemistry: analytical and immunological testing including sample preparation
    • Y10T436/2575—Volumetric liquid transfer

Definitions

  • This invention relates to a medical diagnostic device that includes an element for controlling fluid flow through the device; more particularly, to a device that facilitates fluid flow through a stop junction.
  • a variety of medical diagnostic procedures involve tests on biological fluids, such as blood, urine, or saliva, to determine an analyte concentration in the fluid.
  • the procedures measure a variety of physical parameters - mechanical, optical, electrical, etc., - of the biological fluid.
  • glucose,and dry phase reagent strips incorporating enzyme-based compositions are used extensively in clinical laboratories, physicians' offices, hospitals, and homes to test samples of biological fluids for glucose concentration.
  • reagent strips have become an everyday necessity for many of the nation's estimated 16 million people with diabetes. Since diabetes can cause dangerous anomalies in blood chemistry, it can contribute to vision loss, kidney failure, and other serious medical consequences. To minimize the risk of these consequences, most people with diabetes must test themselves periodically, then adjust their glucose concentration accordingly, for instance, through diet, exercise, and/or insulin injections. Some patients must test their blood glucose concentration as often as four times or more daily.
  • the reagent generally includes an enzyme, such as glucose oxidase or glucose dehydrogenase, and a redox mediator, such as ferrocene or ferricyanide.
  • an enzyme such as glucose oxidase or glucose dehydrogenase
  • a redox mediator such as ferrocene or ferricyanide.
  • the metallized layers constitute first and second electrodes, and a cutout in the adhesive-coated layer defines an electrochemical cell.
  • the cell contains the reagent that reacts with the glucose in a blood sample.
  • the device is elongated, and the sample is introduced at an inlet on one of the long sides.
  • the electrochemical devices for measuring blood glucose that are described in the patents cited above, as well as other medical diagnostic devices used for measuring analyte concentrations or characteristics of biological fluids, generally share a need to transport the fluid from a sample inlet to one or more other sections of the device. Typically, a sample flows through capillary channels between two spaced-apart surfaces.
  • U.S. Patent 4,426,451 issued on January 17, 1984 to Columbus, discloses a multi-zone fluidic device that has pressure-actuatable means for controlling the flow of fluid between the zones. His device makes use of pressure balances on a liquid meniscus at the interface between a first zone and a second zone that has a different cross section. When both the first and second zones are at atmospheric pressure, surface tension creates a back pressure that stops the liquid meniscus from proceeding from the first zone to the second.
  • the configuration of this interface or "stop junction" is such that the liquid flows into the second zone only upon application of an externally generated pressure to the liquid in the first zone that is sufficient to push the meniscus into the second zone.
  • U.S. Patent 5,230,866 issued on July 27, 1993 to Shartle et al., discloses a fluidic device with multiple stop junctions in which the surface tension-induced back pressure at the stop junction is augmented; for example, by trapping and compressing gas in the second zone. The compressed gas can then be vented before applying additional hydrostatic pressure to the first zone to cause fluid to flow into the second zone.
  • "rupture junctions" can be formed, having lower maximum back pressure.
  • U.S. Patent 5,472,603, issued on December 5, 1995 to Schembri discloses using centrifugal force to overcome the back pressure in a stop junction.
  • the first zone is at atmospheric pressure plus a centrifugally generated pressure that is less than the pressure required to overcome the back pressure.
  • the second zone is at atmospheric pressure.
  • additional centrifugal pressure is applied to the first zone, overcoming the meniscus back pressure.
  • the second zone remains at atmospheric pressure.
  • U.S. Patent 6,011,307 issued on December 14,1999, to Naka et al., published on October 29, 1997, discloses a device and method for analyzing a sample that includes drawing the sample into the device by suction, then reacting the sample with a reagent in an analytical section. Analysis is done by optical or electrochemical means. In alternate embodiments, there are multiple to analytical sections and/or a bypass channel.
  • U.S. Patent 5,700,695 issued on December 23, 1997 to Yassinzadeh et aL, discloses an apparatus for collecting and manipulating a biological fluid that uses a "thermal pressure chamber" to provide the driving force for moving the sample through the apparatus.
  • U.S. Patent 5,736,404 issued on April 7, 1998, to Yassinzadeh et aL, discloses a method for determining the coagulation time of a blood sample that involves causing an end of the sample to oscillate within a passageway. The oscillating motion is caused by alternately increasing and decreasing the pressure on the sample.
  • This invention provides a medical device for measuring an analyte concentration or property of a biological fluid.
  • This embodiment of the device comprises
  • Devices of the present invention provide, in a capillary flow channel of the device, a stop junction that is angular in the flow direction. Such a stop junction can be designed with readily-controlled breakthrough pressure. Note that in the present specification and the figures, capillaries are shown bounded by parallel plates. In that case, the "second direction", which has the capillary dimension, is uniquely determined.
  • a discontinuity in channel cross section can form a "stop junction," which can stop the fluid flow, as described in U.S. Patents 4,426,451; 5,230,866; and 5,912,134,
  • the stop junction results from surface tension that creates a back pressure that stops the fluid meniscus from proceeding through the discontinuity.
  • the stop junction is weakened, and flow thereby enhanced, when the leading edge of the meniscus encounters the vertex of an acute angle and is then stretched along the arms of the angle. This may be described as the angle "pointing" in a direction opposite to the direction of fluid flow.
  • This invention relates to a medical diagnostic device that has a flow channel with a stop junction.
  • the stop junction is angular in the direction of flow, which permits fluid in the channel to break through. the stop junction when there is a predetermined pressure difference across the stop junction.
  • Fig. 1 depicts part of a medical diagnostic strip 10 that is a multilayer sandwich.
  • Top layer 12 and bottom layer 14 sandwich intermediate layer 16.
  • a cutout in intermediate layer 16 forms channel 18.
  • Lines 20 and 20A are scored into the bottom surface of layer 12 and form in channel 18 stop junctions 21 and 21A, respectively.
  • sample S introduced into channel 18 at sample inlet 22, stops when it reaches stop junction 21.
  • Figs. 2 and 3 depict the part of a medical to diagnostic strip of Fig. 1 in which stop junctions 21 and 21A have been modified by adding serrations 24 and 24A, respectively.
  • Serration 24 forms an acute angle A that "points" toward sample inlet 22.
  • Figs. 2 and 3 depict sample S just before and just after it breaks through stop junction 21, respectively. Note that the breakthrough occurs first at the vertex that points opposite to the direction of fluid flow.
  • the effectiveness of the serration in enhancing flow through a stop junction in a capillary channel depends on the angle and the length of the legs that form the angle. The smaller the angle and the longer the legs, the greater the effectiveness of the serration.
  • angle A is less than about 90° and its axis of symmetry is aligned with the direction of flow in the channel.
  • Stop junction 21A has an angle that points toward end 26 of channel 18 that is opposite inlet 22, and it would have reduced resistance to the flow of sample that entered end 26.
  • Figs. 4 and depict the flow of sample through channel 18 after it has broken through stop junction 21.
  • the sample is stopped at stop junction 21A.
  • Fig. 5 sample has passed through stop junction 21A at its two ends. The breakthroughs occur there, because although the angles at the two ends are greater than 90°, they are smaller than the angle (i.e., the supplement of the angle that points toward 26) at the center of serration 24A.
  • Fig. 6 is an exploded perspective view of an embodiment of the present invention.
  • the diagnostic device 30 has a top layer 32 and bottom layer 34 sandwiching intermediate layer 36. Elements of the device are formed by the layers, together with cutouts in them. Depicted in Fig. 6 are sample inlet 38, formed by coaligned holes in intermediate layer 66 and top layer 32; first capillary channel 40, for conveying sample from sample inlet 38 to branching point 42; and capillary connecting channel 44, for conveying sample through measurement area 46 to a first stop junction 48. Stop junction 48 is formed by the intersection of the capillary neck, at the end of measurement area 46, and the coinciding holes 48A, 48B, and 48C in intermediate layer 36, top layer 32, and bottom layer 34, respectively.
  • Measurement area 46 preferably contains a reagent 50.
  • Cutout 58. is part of a bladder that includes the adjoining regions of top layer 32 and bottom layer 34.
  • Capillary bypass channel 52 provides an alternate path from branching point 42 to overflow region 54.
  • a stop junction 56 in bypass channel 52 impedes flow into overflow region 54.
  • Stop junction 56 is formed by the intersection of capillary bypass channel 52 and the coinciding holes 56A, 56B, and 56C in intermediate layer 36, top layer 32, and bottom layer 34, respectively. (Either hole 56B or 56C can be omitted). Note that stop junctions 48 and 56 also require seals 48D, 48E, and 56D, 56E, respectively.
  • Fig. 7 is a top plan view of the device of Fig. 6.
  • the device depicted in Figs. 6 and 7 is particularly well suited for measuring blood-clotting time - "prothrombin time” or "PT time” - and details regarding such a device appear below.
  • the modifications needed to adapt the device for other medical diagnostic applications require no more than routine experimentation.
  • sample is applied to sample port 38 after bladder 58 has been compressed.
  • the region of top layer 32 and/or bottom layer 34 that adjoins the cutout for bladder 58 must be resilient, to permit bladder 58 to be compressed. When the bladder is released, suction draws sample through first capillary channel 40 to branching point 42 and through capillary connecting channel 44 to measurement area 46.
  • the volume of bladder 58 is preferably at least about equal to the combined volume of first channel 40, connecting channel 44, capillary bypass channel 52, and measurement area 46.
  • the measurement method is optical, and the measurement area 46 is to be illuminated from below, bottom layer 34 must be transparent where it adjoins measurement area 46.
  • reagent 50 contains thromboplastin that is free of bulking reagents normally found in lyophilized reagents.
  • sample is drawn into the device by suction, caused by decompression of bladder 88.
  • stop junction 48 sample flow stops.
  • Figs. 7A, 7B, and 7C depict a time sequence during which a sample is drawn into device 30 for the measurement.
  • Fig. 7A depicts the situation after a user has applied a sample to the strip, while bladder 58 is compressed. This can be accomplished by applying one or more drops of blood.
  • Fig. 7B depicts the situation after the bladder is decompressed.
  • the resulting reduced pressure in the first channel 40 and connecting channel 44 draws the sample initially into the measurement area 46.
  • stop junction 48 When the sample reaches stop junction 48, the sample encounters a back pressure that causes it to stop and causes additional sample to be drawn into the bypass channel toward stop junction 56.
  • stop junction 56 is "weaker” than stop junction 48, because it has an angle A that points toward branching point 42. (See Figs. 1-5).
  • weak stop junction 56 performs two functions. It first impedes the flow of sample into overflow region 54, thus permitting measurement area 46 to fill rapidly. Second, it permits any excess sample to flow through it (after measurement area 46 is full) to relieve any pressure difference remaining on the two sides of stop junction 48. Such a pressure difference could cause sample to "leak” through stop junction 48, causing movement of sample through the measurement area, which is undesirable, for the reason discussed earlier.
  • Fig. 7C depicts the situation when an equilibrium has been established among the pressures on the sample surfaces - atmospheric pressure on the sample in inlet 38 and the pressure on the free surfaces in overflow region 54 and stop junction 48.
  • Fig. 8 depicts a preferred embodiment of the present device that includes three measurement areas.
  • measurement area 146 contains thromboplastin.
  • measurement areas 146A and 146B contain controls, more preferably, the controls described below.
  • Area 146A contains thromboplastin, bovine eluate, and recombinant Factor VIIa.
  • the composition is selected to normalize the clotting time of a blood sample by counteracting the effect of an anticoagulant, such as warfarin.
  • Measurement area 146B contains thromboplastin and bovine eluate alone, to partially overcome the effect of an anticoagulent.
  • three measurements are made on the strip.
  • PT time of the sample the measurement of primary interest, is measured on area 146. However, that measurement is validated only when measurements on areas 146A and 146B yield results within a predetermined range. If either or both of these control measurements are outside the range, then a retest is indicated.
  • Extended stop junction 148 stops flow in all three measurement areas. Stop junction 156, in bypass channel 152, functions as described above.

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Claims (10)

  1. Dispositif de diagnostic médical (30) pour mesurer la concentration d'une substance à analyser ou définir les propriétés d'un fluide biologique, comprenant :
    a) une couche supérieure (32), une couche de fond (34) et une couche intermédiaire (36) ;
    b) une voie d'entrée des échantillons (38) pour introduire un échantillon du fluide biologique dans le dispositif ;
    c) un premier canal capillaire (40) pour transporter l'échantillon de la voie d'entrée au point de dérivation (42) ;
    d) un canal de raccordement capillaire (44) pour transporter une première partie de l'échantillon depuis le point de dérivation (42) à travers une zone de mesure (46), dans laquelle un paramètre physique de l'échantillon en rapport avec la concentration d'une substance à analyser ou la propriété du fluide est mesuré, et jusqu'à une première jonction d'arrêt (48) ;
    e) un canal de pontage capillaire (52) pour transporter une seconde partie de l'échantillon dans une première direction d'une première région, à proximité du point de dérivation (42), jusqu'à une région de débordement (54), distante du point de dérivation, la première région ayant une dimension capillaire dans une seconde direction sensiblement perpendiculaire à la première direction ;
    f) une seconde jonction d'arrêt (56) dans le canal de pontage, comprenant une région de limite qui :
    i) sépare la première région et la région de débordement ;
    ii) a une seconde dimension prédéterminée dans la seconde direction qui est supérieure à la dimension capillaire ; et
    iii) forme un angle dirigé vers la première région ;
       moyennant quoi un échantillon en surplus entrant dans la voie d'entrée des échantillons (38) passera à travers la seconde jonction d'arrêt (56) dans la région de débordement (54) ;
       caractérisé en ce que la seconde direction est perpendiculaire au plan des couches (32, 34, 36) et en ce que la region de limite forme un angle dans le plan des couches (32, 34, 36).
  2. Dispositif selon la revendication 1, comprenant en outre un dispositif d'aspiration (58), en communication fluidique avec la première (48) et la seconde (52) jonctions d'arrêt, pour tirer l'échantillon de la voie d'entrée d'échantillon (38) vers les jonctions d'arrêt.
  3. Dispositif selon la revendication 2, dans lequel au moins une de la première couche (32) et de la seconde couche (34) a une région élastique sur au moins une partie de sa superficie, séparée par une couche intermédiaire (36), et dans lequel :
    a) des découpes dans les couches forment, avec les couches, la voie d'entrée des échantillons (38), le premier canal (40), le canal de raccordement (44), la zone de mesure (46) et le canal de pontage (52) ;
    b) le dispositif d'aspiration comprend une vessie (58) qui :
    i) est distante de la voie d'entrée des échantillons ;
    ii) comprend au moins une partie de la région élastique ; et
    iii) a un volume qui est au moins environ égal au volume combiné du premier canal, de la zone de mesure, du canal de raccordement et du canal de pontage ; et
    c) la première et la seconde jonctions d'arrêt comprennent des orifices coïncidant (56A, 56B, 56C) dans la première et la seconde couches ainsi que dans la couche intermédiaire qui sont prises en sandwich par une troisième et une quatrième couches.
  4. Dispositif selon la revendication 3, dans lequel au moins la première (32) ou la seconde couche (34) est sensiblement transparente et adjacente à la zone de mesure (46), le paramètre physique qui est mesuré étant la transmission optique.
  5. Dispositif selon la revendication 3 ou la revendication 4, dans lequel le paramètre physique de l'échantillon subit une modification dans la zone de mesure (46).
  6. Dispositif selon la revendication 5, dans lequel la zone de mesure contient une composition qui facilite la coagulation du sang, le fluide biologique est du sang entier, et la propriété mesurée est la durée de la prothrombine.
  7. Dispositif selon la revendication 6, dans lequel la composition comprend de la thromboplastine.
  8. Dispositif selon la revendication 6 ou la revendication 7, comprenant en outre au moins un passage fluidique supplémentaire depuis le point de dérivation jusqu'à la vessie, chacun desdits passages suppléant comprenant une zone de mesure et une jonction d'arrêt correspondantes.
  9. Dispositif selon la revendication 8, dans lequel un premier passage suppléant va vers une zone de mesure qui surmonte l'effet d'un anticoagulant et un second passage suppléant va vers une zone de mesure qui surmonte partiellement l'effet d'un anticoagulant.
  10. Dispositif selon la revendication 9, dans lequel la zone de mesure dans le premier passage suppléant comprend de la thromboplastine, de l'éluat de bovin et du facteur VIIa recombinant et la zone de mesure dans le second passage suppléant comprend de la thromboplastine et de l'éluat de bovin.
EP01937160A 2000-03-31 2001-03-22 Regulation d'ecoulement capillaire dans un dispositif de diagnostique fluidique Expired - Lifetime EP1280602B1 (fr)

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Application Number Priority Date Filing Date Title
DK01937160T DK1280602T3 (da) 2000-03-31 2001-03-22 Kapillargennemströmningsregulering i en diagnostisk fluidindretning

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US541376 2000-03-31
US09/541,376 US6908593B1 (en) 2000-03-31 2000-03-31 Capillary flow control in a fluidic diagnostic device
PCT/US2001/009237 WO2001075433A2 (fr) 2000-03-31 2001-03-22 Regulation d'ecoulement capillaire dans un dispositif de diagnostique fluidique

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EP1280602B1 true EP1280602B1 (fr) 2005-05-11

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US (1) US6908593B1 (fr)
EP (1) EP1280602B1 (fr)
JP (1) JP2003529763A (fr)
KR (1) KR20020087448A (fr)
CN (1) CN1238112C (fr)
AR (1) AR028529A1 (fr)
AT (1) ATE295227T1 (fr)
AU (2) AU6292301A (fr)
CA (1) CA2404521A1 (fr)
CZ (1) CZ20023250A3 (fr)
DE (1) DE60110781T2 (fr)
ES (1) ES2241828T3 (fr)
HK (1) HK1050650A1 (fr)
IL (1) IL151965A0 (fr)
MX (1) MXPA02009700A (fr)
MY (1) MY134187A (fr)
PL (1) PL357113A1 (fr)
PT (1) PT1280602E (fr)
RU (1) RU2238147C2 (fr)
TW (1) TW519567B (fr)
WO (1) WO2001075433A2 (fr)

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AU2001262923B2 (en) 2005-02-03
MXPA02009700A (es) 2004-09-06
HK1050650A1 (en) 2003-07-04
WO2001075433A2 (fr) 2001-10-11
AR028529A1 (es) 2003-05-14
WO2001075433A3 (fr) 2002-03-14
JP2003529763A (ja) 2003-10-07
PL357113A1 (en) 2004-07-12
ES2241828T3 (es) 2005-11-01
DE60110781D1 (de) 2005-06-16
ATE295227T1 (de) 2005-05-15
KR20020087448A (ko) 2002-11-22
CA2404521A1 (fr) 2001-10-11
AU6292301A (en) 2001-10-15
CN1238112C (zh) 2006-01-25
RU2238147C2 (ru) 2004-10-20
PT1280602E (pt) 2005-07-29
TW519567B (en) 2003-02-01
DE60110781T2 (de) 2006-02-23
CZ20023250A3 (cs) 2003-06-18
MY134187A (en) 2007-11-30
CN1422180A (zh) 2003-06-04
EP1280602A2 (fr) 2003-02-05
RU2002125858A (ru) 2004-03-10
US6908593B1 (en) 2005-06-21
IL151965A0 (en) 2003-04-10

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